Safety and Dose-Response of Bletilla Formosana in Prediabetic Subjects
A Phase I/II Randomized, Double-Blind, Placebo-Controlled Pilot Trial Evaluating the Safety and Dose-Response of Bletilla Formosana in Prediabetic Subjects
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
This is a single-center, Phase I/II, randomized, double-blind, placebo-controlled, parallel-design trial. The primary goal is to translate robust preclinical findings-where BF extract was shown to inhibit neutrophil-driven inflammation and improve glycemic parameters in animal models-into clinical evidence.
A total of 94 prediabetic subjects (defined by FPG 100-125 mg/dL or HbA1c 5.7%-6.4%) will be enrolled.
Participants will be randomized in a 2:2:1 ratio into one of the following three arms:
High-dose group: 3g Bletilla formosana powder daily. Low-dose group: 1.5g Bletilla formosana powder plus 1.5g placebo daily. Placebo group: 3g inactive placebo powder daily.
The study consists of three distinct phases:
Screening Phase: Up to 2 weeks for eligibility confirmation. Treatment Phase: 12 weeks of oral administration. Follow-up Phase: 12 weeks post-treatment to evaluate sustained efficacy and safety outcomes.
Phase I objectives focus on safety and tolerability, with adverse events (AEs) and serious adverse events (SAEs) graded according to CTCAE v5.0.
Phase II objectives explore preliminary efficacy through changes in fasting plasma glucose (FPG), HbA1c, and HOMA-IR.
Secondary endpoints include assessment of inflammatory biomarkers (TNF-α, IL-6, and CRP) and lipid profiles.
Clinical assessments, including 12-lead ECG and comprehensive laboratory testing, are scheduled at Screening, Week 6, Week 12 (end of treatment), and Week 24 (end of study).
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Faza
Faza
- Faza 2
- Faza 1
Kontakty i lokalizacje
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: Yuan-Chieh Yeh, MD
- Numer telefonu: 6320 +886-2-24313131
- E-mail: b9005030@cgmh.org.tw
Kopia zapasowa kontaktu do badania
- Nazwa: Yu-Chieh Peng, Bachelor
- Numer telefonu: +886-2-2431-2540
- E-mail: sunnypon1013@gmail.com
Lokalizacje studiów
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Keelung, Tajwan, 204
- Keelung Chang Gung Memorial Hospital
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Kontakt:
- Yu-Chieh Peng, Bachelor
- Numer telefonu: +886-2-2431-2540
- E-mail: sunnypon1013@gmail.com
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Kontakt:
- Yuan-Chieh Yeh, MD
- Numer telefonu: 6320 +886-2-24313131
- E-mail: b9005030@gmail.com
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Główny śledczy:
- Yuan-Chieh Yeh, MD
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Taoyuan, Tajwan, 333
- Taoyuan Chang Gung Memorial Hospital
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Kontakt:
- Yu-Chieh Peng, Bachelor
- Numer telefonu: +886-2-2431-2540
- E-mail: sunnypon1013@gmail.com
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Kontakt:
- Hsing-Yu Chen, MD
- Numer telefonu: +886-975366119
- E-mail: 8705016@cgmh.org.tw
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Taoyuan, Tajwan, 333
- Linkou Chang Gung Memorial Hospital
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Kontakt:
- Yu-Chieh Peng, Bachelor
- Numer telefonu: +886-2-2431-2540
- E-mail: sunnypon1013@gmail.com
-
Kontakt:
- Hsing-Yu Chen, MD
- Numer telefonu: +886-975366119
- E-mail: 8705016@cgmh.org.tw
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Główny śledczy:
- Hsing-Yu Chen, MD
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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Adults aged 30-70 years.
- Prediabetes defined by any of the following:
- Fasting Plasma Glucose (FPG) of 100-125 mg/dL, or
- Glycated hemoglobin (HbA1c) of 5.7%-6.4%.
- Willingness to provide written informed consent and comply with study procedures.
Exclusion Criteria:
- Established type 1 or type 2 diabetes mellitus, or recent use of oral antidiabetic agents or insulin (within 3 months).
- Abnormal liver function, defined as Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) exceeding 2-fold the upper reference limit (≥2 × ULN) at screening.
- Abnormal renal function, defined as serum creatinine (Cr) >1.5 mg/dL or Estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73 m².
- Gastrointestinal disorders that may affect drug absorption, such as gastrostomy, enterostomy, severe chronic diarrhea, or malabsorption syndrome.
- Severe comorbidities within the past 6 months, including major stroke, myocardial infarction, major trauma, or major surgery.
- Recent use of medications (within 1 month) that may significantly alter blood glucose or lipids, such as systemic corticosteroids or non-stable doses of lipid-lowering agents.
- Malignant tumor under active treatment, or immunodeficiency/autoimmune disorders requiring immunosuppressive therapy.
- Psychiatric disorders or cognitive impairment that may affect protocol compliance.
- Active use of other investigational drugs within 3 months prior to screening.
- Pregnancy or lactation.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
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Eksperymentalny: High-dose Bletilla formosana (BF)
Participants receive 3g of Bletilla formosana powder daily for 12 weeks.
To maintain blinding, the total dose is divided into two 1.5g sachets (one in the morning and one in the evening).
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A traditional Chinese medicinal herb (Taiwanese ground orchid).
The raw material is derived from the approved botanical species and medicinal part listed in the Taiwan Herbal Pharmacopoeia.
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Eksperymentalny: Low-dose Bletilla formosana (BF)
Participants receive 1.5g of Bletilla formosana powder and 1.5g of placebo powder daily for 12 weeks.
To maintain blinding, this is administered as one active sachet and one matching placebo sachet (one in the morning and one in the evening).
|
A traditional Chinese medicinal herb (Taiwanese ground orchid).
The raw material is derived from the approved botanical species and medicinal part listed in the Taiwan Herbal Pharmacopoeia.
An inactive powder matching the appearance and dosage form of the BF powder, consisting of starch and caramel coloring.
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Komparator placebo: Placebo
Participants receive 3g of inactive placebo powder daily for 12 weeks.
To maintain blinding, this is administered as two matching placebo sachets (one in the morning and one in the evening).
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An inactive powder matching the appearance and dosage form of the BF powder, consisting of starch and caramel coloring.
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Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Number of Participants with at Least One Treatment-Emergent Adverse Event (AE)
Ramy czasowe: From baseline to Week 24.
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Incidence of all adverse events (AEs) graded by CTCAE v5.0.
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From baseline to Week 24.
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Number of Participants with Serious Adverse Events (SAEs)
Ramy czasowe: From baseline to Week 24
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Number of participants experiencing life-threatening or fatal events according to ICH-GCP definitions.
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From baseline to Week 24
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Change from Baseline in Fasting Plasma Glucose (FPG) (mg/dL)
Ramy czasowe: Baseline, Week 6, Week 12, and Week 24.
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Change in fasting blood sugar levels to assess the preliminary glycemic efficacy of Bletilla formosana.
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Baseline, Week 6, Week 12, and Week 24.
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Change from Baseline in Glycated Hemoglobin (HbA1c) (%)
Ramy czasowe: Baseline, Week 6, Week 12, and Week 24.
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Assessment of average blood glucose control over time.
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Baseline, Week 6, Week 12, and Week 24.
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Change from Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Ramy czasowe: Baseline, Week 6, Week 12, and Week 24.
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Calculated using fasting insulin and glucose levels to assess changes in insulin sensitivity.
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Baseline, Week 6, Week 12, and Week 24.
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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change from Baseline in Tumor Necrosis Factor-alpha (TNF-α) (pg/mL)
Ramy czasowe: Baseline, Week 6, Week 12, and Week 24.
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To evaluate the anti-inflammatory effects of Bletilla formosana.
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Baseline, Week 6, Week 12, and Week 24.
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Change from Baseline in Interleukin-6 (IL-6) (pg/mL)
Ramy czasowe: Baseline, Week 6, Week 12, and Week 24.
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To evaluate the anti-inflammatory effects of Bletilla formosana.
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Baseline, Week 6, Week 12, and Week 24.
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Change from Baseline in C-reactive protein (CRP) (mg/dL)
Ramy czasowe: Baseline, Week 6, Week 12, and Week 24.
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To evaluate the anti-inflammatory effects of Bletilla formosana.
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Baseline, Week 6, Week 12, and Week 24.
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Change from Baseline in Total Cholesterol (mg/dL)
Ramy czasowe: Baseline, Week 6, Week 12, and Week 24.
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Assessment of lipid profiles using standard laboratory methods
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Baseline, Week 6, Week 12, and Week 24.
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Change from Baseline in High-Density Lipoprotein (HDL) (mg/dL)
Ramy czasowe: Baseline, Week 6, Week 12, and Week 24.
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Assessment of lipid profiles using standard laboratory methods.
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Baseline, Week 6, Week 12, and Week 24.
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Change from Baseline in Low-Density Lipoprotein (LDL) (mg/dL)
Ramy czasowe: Baseline, Week 6, Week 12, and Week 24.
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Assessment of lipid profiles using standard laboratory methods.
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Baseline, Week 6, Week 12, and Week 24.
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Change from Baseline in Triglycerides (TG) (mg/dL)
Ramy czasowe: Baseline, Week 6, Week 12, and Week 24.
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Assessment of lipid profiles using standard laboratory methods.
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Baseline, Week 6, Week 12, and Week 24.
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Inne miary wyników
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change from Baseline in Alanine Aminotransferase (ALT) (U/L)
Ramy czasowe: Baseline, Week 6, Week 12, and Week 24.
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Assessment of clinical laboratory safety tests to monitor hepatic, renal, and hematologic function.
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Baseline, Week 6, Week 12, and Week 24.
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Change from Baseline in Aspartate Aminotransferase (AST) (U/L)
Ramy czasowe: Baseline, Week 6, Week 12, and Week 24.
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Assessment of clinical laboratory safety tests to monitor hepatic, renal, and hematologic function.
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Baseline, Week 6, Week 12, and Week 24.
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Change from Baseline in Total Bilirubin (mg/dL)
Ramy czasowe: Baseline, Week 6, Week 12, and Week 24.
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Assessment of clinical laboratory safety tests to monitor hepatic, renal, and hematologic function.
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Baseline, Week 6, Week 12, and Week 24.
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Change from Baseline in Blood Urea Nitrogen (BUN) (mg/dL)
Ramy czasowe: Baseline, Week 6, Week 12, and Week 24.
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Assessment of clinical laboratory safety tests to monitor hepatic, renal, and hematologic function.
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Baseline, Week 6, Week 12, and Week 24.
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Change from Baseline in Serum Creatinine (mg/dL)
Ramy czasowe: Baseline, Week 6, Week 12, and Week 24.
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Assessment of clinical laboratory safety tests to monitor hepatic, renal, and hematologic function.
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Baseline, Week 6, Week 12, and Week 24.
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Change from Baseline in White Blood Cell Count (WBC) (10^3/μL)
Ramy czasowe: Baseline, Week 6, Week 12, and Week 24.
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Assessment of clinical laboratory safety tests to monitor hepatic, renal, and hematologic function.
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Baseline, Week 6, Week 12, and Week 24.
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Change from Baseline in Hemoglobin (Hb) (g/dL)
Ramy czasowe: Baseline, Week 6, Week 12, and Week 24.
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Assessment of clinical laboratory safety tests to monitor hepatic, renal, and hematologic function.
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Baseline, Week 6, Week 12, and Week 24.
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Change from Baseline in Platelet Count (10^3/μL)
Ramy czasowe: Baseline, Week 6, Week 12, and Week 24.
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Assessment of clinical laboratory safety tests to monitor hepatic, renal, and hematologic function.
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Baseline, Week 6, Week 12, and Week 24.
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Współpracownicy i badacze
Sponsor
Sponsor
Współpracownicy
Współpracownicy
Śledczy
Śledczy
- Główny śledczy: Yuan-Chieh Yeh, MD, Chang Gung Memorial Hospital
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- 202500720A3C6002
- NSTC 114-2321-B-255-001 (Inny numer grantu/finansowania: National Science and Technology Council)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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